The Model 2127-900 Series Endoscope Adapter is an accessory for the Clarus Medical Systems Model 2127 Endoscope. It is intended to be reusable. It is used to temporarily clamp or hold the endoscope when mounting to an airway catheter.

MOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN

Device Description

The Model 2127-900 Series Endoscope Adapter is a machined or molded plastic piece used to hold an endoscope and airway catheter together. The endoscope adapter has a machined or molded tapered hub designed to fit firmly into the proximal end of various airway catheters. Additionally the endoscope adapter has a central hole designed to fit the outside diameter of the shaft on the appropriate legally marketed Clarus Model 2127 Endoscope.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the format you requested.

The document describes a 510(k) submission for the Clarus Model 2127-900 Series Endoscope Adapter and primarily focuses on:

Device Description: What the device is and how it works.
Intended Use: The purpose of the device.
Testing: It mentions "Biocompatibility testing" and "Physical testing" (disinfecting solution exposure, workmanship examination, dimensional measurements, material certification) as having been performed, and that the material "passed biocompatibility testing and is suitable for this application."
Substantial Equivalence: It explains how the device is substantially equivalent to a predicate device.
FDA Clearance Letter: The formal letter from the FDA stating clearance for marketing.

However, the text does not include:

A table of specific acceptance criteria.
Reported device performance against numerical thresholds.
Details about a study design, sample sizes (for test or training sets), data provenance, expert qualifications, or adjudication methods for establishing ground truth.
Any information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.

It merely states that certain tests were done and passed, which is a high-level summary rather than a detailed study report with specific acceptance criteria and performance data.

Summary

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MAY 2 3 1997

A 4711585

tg 1 of 2

510(k) Summary

Model 2127-900 Series Endoscope Adapter

General Information

Classifications	Class II Accessory
Trade Name	Clarus Model 2127-900 Series Endoscope Adapter
Submitted	Clarus Medical Systems, Inc.1000 Boone Avenue North, #100Minneapolis, MN 55427
Contact	Dale SappenfieldVice President Engineering and Quality

Device Description

Intended Use

Testing

Biocompatibility testing was done on the material used in the endoscope adapter. The material passed biocompatibility testing and is suitable for this application.

Physical testing included disinfecting solution (2% glutaraldehyde) exposure testing, examination for workmanship, dimensional measurements and certification of material.

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Summary of Substantial Equivalence

The Model 2127-900 Series Endoscope Adapter is an accessory to a Model 2127 Clarus Endoscope. When used with the appropriate endoscope, the endoscope adapter augments the capabilities of the endoscope by acting as a clamping and holding devise to temporarily mount the endoscope to and airway catheter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a person with outstretched arms, representing care and protection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 1997

Mr. Dale Sappenfield Vice President, Engineering & Quality Clarus Medical Systems, Inc. 1000 Boone Avenue North Minneapolis, Minnesota 55427

Re: K971584 Clarus Model #2127-900 Series Endoscope Adapter Dated: May 13, 1997 Received: May 16, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG

Dear Mr. Sappenfield:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: CLARDS HODEL 2127- 900 SERIES GODDECOPE

Indications For Use:

HOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Anthony

(Division Sign-Off) Devision of Reproductive, Abdominal, ENT, and Radiological Devices

x(k) Number k-97115-1

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.